FDA Approves Expanded Adjuvant Indications for Herceptin

May 23, 2008

US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

US Food and Drug Administration’s Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

Herceptin can now be included as part of a treatment regimen containing doxorubicin, cyclophosphamide, and docetaxel, and also as part of another regimen containing docetaxel and carboplatin, for the adjuvant treatment of HER2 overexpressing, node-positive, or high-risk node-negative breast cancer.

Herceptin first received FDA approval in September 1998 for use in women with metastatic breast cancer, as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy.

In January 2008, Herceptin was also approved as a single agent for the adjuvant treatment of HER2-overexpressing node-negative or node-positive breast cancer, following multimodality anthracycline-based therapy.

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